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BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma - PubMed
Source : https://pubmed.ncbi.nlm.nih.gov/36377973/
Treatment with covalent Bruton tyrosine kinase inhibitors (BTKi) represents an important advance in the management of relapsed or refractory mantle cell lymphoma, but these treatments are not curative and many patients ultimately relapse. Pirtobrutinib, a highly selective, noncovalent (reversible) B ...
Conclusions: This phase III, head-to-head, randomized study (NCT04662255) will evaluate whether pirtobrutinib is superior to investigator’s choice of covalent BTKi in patients with previously treated, BTKi-naive mantle cell lymphoma.
• Source: Future Medicine
• Relevance: “Pirtobrutinib is well tolerated and has demonstrated promising efficacy in patients with poor prognosis B-cell malignancies following prior therapy, including covalent BTKi. This phase III, head-to-head, randomized study (NCT04662255) will evaluate whether pirtobrutinib is superior to investigator’s choice of covalent BTKi in patients with previously treated, BTKi-naive mantle cell lymphoma.”
• Although treatment with covalent BTK inhibitors is a breakthrough for refractory mantle cell lymphoma, such interventions are not curative, with patients ultimately relapsing.
• Pirtobrutinib is a highly selective, noncovalent (reversible) BTKi that blocks wild type and C481-mutant BTK with equal low nM potency. Oral pharmacology permits continuous BTK inhibition via the dosing interval—despite the intrinsic rate of BTK turnover.
• “The results of this key study will generate important data characterizing the differences in safety, tolerability and efficacy between pirtobrutinib and covalent BTK inhibitors (ibrutinib, acalabrutinib and zanubrutinib) in this patient population,” the U.S., U.K., and international investigators predicted.